600 Participants NeededMy employer runs this trial

Mindfulness-Based Intervention for Smoking Cessation

SD
MH
Overseen ByMarilyn Horta, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mindfulness program called MBRP-SA to help cancer survivors quit smoking and reduce risky alcohol use. Participants will either attend online mindfulness sessions or receive assistance from the Florida Tobacco Quitline, with additional support for alcohol use. It is ideal for Florida cancer survivors who have recently smoked, experienced a binge drinking episode, and wish to quit smoking within the next month. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance health outcomes for cancer survivors.

Do I have to stop taking my current medications for the trial?

The trial requires that you are not currently using any tobacco cessation medications or treatments to quit smoking. Other medications are not mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) is safe. Studies have found no side effects or harmful events linked to this mindfulness treatment. Participants experienced no negative effects from the mindfulness sessions. Overall, the treatment is easy to handle, making it a promising choice for those wanting to reduce smoking and alcohol use.12345

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) because it offers a fresh approach compared to traditional methods like nicotine replacement therapies or prescription medications. This treatment focuses on mindfulness techniques, helping individuals become more aware of their cravings and responses, which can lead to better self-control and reduced relapse rates. Delivered via Zoom in a group format, it also provides increased accessibility and convenience, making it easier for participants to engage consistently. Additionally, the Quitline Support arm connects participants to the Florida Tobacco Quitline, offering personalized support and community referrals, which complements the mindfulness approach and enhances overall support for smoking cessation.

What evidence suggests that this trial's treatments could be effective for smoking cessation and alcohol use?

This trial will compare Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) with Quitline Support for smoking cessation. Studies have shown that MBRP-SA can help people quit smoking and reduce alcohol consumption. One large study found that MBRP led to fewer days of heavy drinking compared to traditional cognitive-behavioral therapy (CBT). Another study showed that MBRP was equally effective as CBT in reducing risky drinking and smoking. Research also suggests that MBRP can significantly lower the chance of returning to substance use and heavy drinking compared to usual treatments. These findings support MBRP-SA as a promising method for quitting smoking and reducing alcohol use.26789

Who Is on the Research Team?

CV

Christine Vinci, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults in Florida who have had cancer, currently smoke at least one cigarette a day, and drink more than recommended or binge drink. Participants must want to quit smoking and cut back on alcohol soon, speak English, and not be pregnant or in hospice care.

Inclusion Criteria

I am 18 years old or older.
I have been diagnosed with cancer at some point in my life.
Smoked ≥1 cigarette/day in past month
See 4 more

Exclusion Criteria

Pregnancy or lactation
Household member already enrolled
Active psychotic disorder
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) via Zoom or Quitline Support for smoking cessation and community referrals for alcohol use treatment

8 weeks
Weekly group sessions (virtual)

Follow-up

Participants are monitored for smoking abstinence and alcohol use outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • MBRP-SA

Trial Overview

The study compares a mindfulness-based program (MBRP-SA) designed to help people avoid returning to smoking and heavy drinking with standard Quitline support. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Quitline SupportExperimental Treatment1 Intervention
Group II: Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

Florida Biomedical Research Program - James & Esther King

Collaborator

Citations

Pilot Randomized Controlled Trial of Mindfulness-Based ...

One large-scale study found that Mindfulness-Based Relapse Prevention (MBRP) resulted in fewer heavy drinking days through 12 months than CBT (Bowen et al., ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32222767/

Effectiveness of Mindfulness-Based Relapse Prevention ...

This article presents results from a pilot trial evaluating the feasibility and initial efficacy of Mindfulness-Based Relapse Prevention (MBRP)

Pilot randomized controlled trial of mindfulness-based ...

In sum, MBRP-SA had comparable outcomes to CBT on all metrics measured. Future research should evaluate the efficacy of MBRP-SA on smoking ...

Relative Efficacy of Mindfulness-Based Relapse ...

substance use disorders, RP and MBRP, compared with TAU, produced significantly reduced relapse risk to drug use and heavy drinking. Relapse ...

5.

mindfulrp.com

mindfulrp.com/research

Research

The study provides preliminary data for future studies examining both mechanisms and effectiveness of mindfulness-based interventions for cigarette smoking.

Mindfulness-Based Relapse Prevention for Substance Use ...

The MBRP intervention appears safe as indicated by lack of reported side effects or adverse events. Significant decreases were found in overall days of ...

Mindfulness-Based Intervention for Smoking Cessation

This study will examine the efficacy of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care ...

Mindfulness-based Relapse Prevention for Substance Use ...

We have limited confidence in estimates suggesting MBRP yields small effects on withdrawal/craving and negative consequences versus comparator interventions.

A Mindfulness Based Application for Smoking Cessation

Mindfulness based smoking therapy (MT) has preliminary support for reducing consumption in smokers, and Dr. Judson Brewer has recently translated this program ...